(50 days)
Not Found
No
The document describes a microprocessor-based system using standard physiological measurement techniques (Korotkoff sounds for blood pressure, optical sensor for SpO2) and does not mention AI or ML.
No
The device is intended to measure and display vital signs (blood pressure, heart rate, SpO2) during stress tests, not to treat a medical condition or restore a function.
Yes
The device measures and displays physiological parameters (blood pressure, heart rate, SpO2) in adult patients during stress tests and in various medical facilities, which are used to assess a patient's health status, fitting the definition of a diagnostic device.
No
The device description explicitly mentions hardware components like a microprocessor, electric pump, valves, and an optical finger sensor, indicating it is a hardware device with integrated software.
Based on the provided information, the Tango+ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Tango+ Function: The Tango+ measures physiological parameters directly from the patient's body:
- Blood Pressure: Measured using a cuff and Korotkoff sounds.
- Heart Rate: Derived from the blood pressure measurement or potentially the pulse oximetry.
- Oxygen Saturation (SpO2): Measured using an optical finger sensor.
- No Sample Analysis: The device does not analyze any samples taken from the patient. It directly measures vital signs from the living body.
Therefore, the Tango+ falls under the category of physiological monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Tango+ is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, and percentage of oxygen saturation in arterial blood (SpO2) in adult patients during stress tests.
The SunTech Medical Tango+ Pulse Oximeter and NIBP monitor is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult patients in hospitals, medical facilities, and subacute environments.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Tango+, a microprocessor based ambulatory blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test sytems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. Tango+ has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
hospitals, medical facilities, and subacute environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests:
The Tango+ will have passed the following tests:
- for Electrical Safety EN 60601-1 .
- l EN 60601-1-2 for Electromagnetic Compatibility ANSI/AAMI SP10
The oxygen saturation system has been thoroughly tested.
The components have had biocompatibility tests.
Clinical tests:
The SpO2 system was validated in a clinical test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SunTech Tango, K970629, Nonin Avant 2120, K031487
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
K 053209
SunTech Medical Inc. 510(k) Submission Tango + System for Non-Invasive Blood Pressure and Per Cent Oxygen Saturation
510(K) Summary June 22, 2005
(1) Submitter information
| Name : | SunTech Medical Inc. |
|---|---|
| Address: | 507 Airport Boulevard |
| Morrisville, NC 27560 | |
| Telephone: | 1 919 654-2300 |
| Contact person: | David Gallick (Official Correspondent). |
| SunTech Medical Inc. | |
| 507 Airport Boulevard | |
| Morrisville, NC 27560 | |
| 1 919 654 2332 |
June 22, 2005 Date prepared :
(2) Name of Device
| Trade Name: | Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement
System |
|----------------------|--------------------------------------------------------------------------------------------------|
| Common Name: | Automated Blood Pressure Monitor and Oxygen Saturation measurement
device |
| Classification name: | System, measurement, blood pressure, non-invasive, systolic and/or
diastolic, 74JOE, 870.1130 |
(3) Legally-marketed predicate devices
SunTech Tango, K970629
Nonin Avant 2120, K031487
page 1 of 2
1
Page 5-2
(3) Description
1 11e Tango+, a microprocessor based ambulatory blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test sytems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. Tango+ has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second.
(4) Intended Use
The Tango+ is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, and percentage of oxygen saturation in arterial blood (SpO2) in adult patients during stress tests.
(5) Performance Data
(a) Non-clinical tests
The Tango+ will have passed the following tests:
- for Electrical Safety EN 60601-1 .
- l EN 60601-1-2 for Electromagnetic Compatibility ANSI/AAMI SP10
The oxygen saturation system has been thoroughly tested.
The components have had biocompatibility tests.
(b) Clinical tests
The SpO2 system was validated in a clinical test.
(6) Conclusion
The Tango+ Automated Blood Pressure and Oxygen Saturation Monitor system is equivalent in safety and efficacy to the legally-marketed predicate devices.
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a stylized eagle in the center. The text around the perimeter is difficult to read due to the image quality, but it appears to be the name of a government agency or organization. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract look.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 5 2006
SunTech Medical, Inc. c/o Mr. David Gallick VP of Engineering 507 Airport Boulevard Morrisville, NC 27560
Re: K053209
Trade Name: Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 09, 2005 Received: November 16, 2005
Dear Mr. Gallick:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 – Mr. David Gallick
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimmarfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SunTech Medical
、
√(k) Number (if known): K053209
Indications for Use Form
Device Name: Tango+
Indications for Use:
The SunTech Medical Tango+ Pulse Oximeter and NIBP monitor is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult patients in hospitals, medical facilities, and subacute environments.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhimmer
n Sign-Off) Division of Cardiova 510(k) Nich ber